BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 3090829 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02734
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL WHISPER DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE FOREIGN MATERIAL WAS UNABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE STATES: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). IN THIS CASE, IT DOES NOT APPEAR THE VIOLATION OF THE IFU CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO PLACE A LEAD IN THE LEFT VENTRICLE. A WHISPER GUIDE WIRE WAS BEING ADVANCED THROUGH A LEAD WHEN THE WIRE FELT STICKY. THE WIRE WAS REMOVED AND THE NURSE SAW BLACK DEBRIS ON HER GLOVES. A SECOND WHISPER WIRE WAS ADVANCED AND THE SAME ISSUE OCCURRED. A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192368 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 2122871

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR